FDA.reportPublic FDA data

Premier Value Sleep-Aid

Manufacturer
Chain Drug Consortium LLC | Marksans Pharma Limited
Effective date
2013-05-30
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:35

Label at a glance#

ProductPremier Value Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Dosage and administration

adults and children 12 years of age and over : take 1 softgel at bedtime if needed or as directed by a doctor

Storage and handling

Store at controlled room temperature 15°-30°C (59°-86°F) do not use if imprinted safety seal under cap is broken or missing *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

PURPOSE

OTC - PURPOSE SECTION

Nighttime sleep- aid

USE(S)

INDICATIONS & USAGE SECTION

  • helps to reduce difficulty falling asleep

WARNINGS

WARNINGS SECTION

Do not give to children under 12 years of age.

DO NOT USE

OTC - DO NOT USE SECTION

  • With other products containing diphenhydramine, even one used on skin.

ASK A DOCTOR BEFORE USE IF

OTC - ASK DOCTOR SECTION

  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

OTC - ASK DOCTOR/PHARMACIST SECTION

Sedatives or tranquilizers

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Avoid alcoholic beverages

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  •  Sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

PREGNANCY/BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

STORAGE

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


diphen-carton-labdiphen-carton-lab





Bottle Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


diphen-bott-labeldiphen-bott-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-302-322020-01-31C16284748780-19d75b9d0-c040-f424-e053-dadaa90a57ced52c0cc9-758f-4f38-98db-eee64023d25c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-302-32Premier Value Sleep-Aid1 in 1 CARTONCAPSULE11
68016-302-32Premier Value Sleep-Aid32 in 1 BOTTLECAPSULE321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-302PREMIER VALUE SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM LLC]1Legacy NDC, 2 package rows20130531_d52c0cc9-758f-4f38-98db-eee64023d25c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GELATININACTIVE INGREDIENT2G86QN327L1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
POVIDONE K30INACTIVE INGREDIENTU725QWY32X1
SORBITANINACTIVE INGREDIENT6O92ICV9RU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-30268016-302-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 204 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSOLUTION / OPHTHALMIC42 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, COATED, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSUSPENSION / OPHTHALMIC14 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQOINTMENT / TOPICAL1950 mgExact identifier — unii candidate
36 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XGRANULE, EFFERVESCENT / ORAL40 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSOLUTION / ORAL300 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XINSERT / VAGINAL147 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION/ DROPS / OPHTHALMIC1 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XFILM / SUBLINGUAL7 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSUSPENSION / ORAL148 mgExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SORBITANSORBITAN6O92ICV9RUCAPSULE / ORAL19.08 mgExact identifier — unii candidate
3 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, LIQUID FILLED / ORAL101 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, DELAYED RELEASE / ORAL516 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, DELAYED RELEASE PELLETS / ORAL178 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii candidate
36 equally ranked IID candidates
GELATINGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d52c0cc9-758f-4f38-98db-eee64023d25cd52c0cc9-758f-4f38-98db-eee64023d25c2013-05-30WarningsExact identifier
spl id: d52c0cc9-758f-4f38-98db-eee64023d25c
spl set id: d52c0cc9-758f-4f38-98db-eee64023d25c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.